Sotyktu (deucravacitinib) received FDA approval on March 6, 2026, for treating adults with active psoriatic arthritis, marking the first FDA approval of a TYK2 inhibitor for this indication. The approval was based on results from two Phase III clinical trials: POETYK PsA-I (670 patients) and POETYK PsA-II (624 patients), both demonstrating improvements in disease activity measured by ACR20 response at week 16. Sotyktu is administered as a once-daily 6mg oral dose and represents a second indication for the drug, which was first approved by the FDA in 2022 for moderate-to-severe plaque psoriasis. Common adverse reactions reported in clinical trials include acne, folliculitis, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, and upper respiratory infections. This approval confirms Sotyktu's role in managing both skin and joint symptoms of psoriatic disease. Sources:
- Get link
- X
- Other Apps